Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Volk Optical, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy | Volk Optical, Inc. | 2015-08-18 | 33 | 0 |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, V | Volk Optical, Inc. | 2005-03-28 | 18 | 1 |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | Volk Optical, Inc. | 2002-10-11 | 14 | 1 |
| K943125 | QUADRASPHERIC FUNDUS LENS | Volk Optical, Inc. | 1994-09-02 | 65 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda